Ospemifene

(Osphena®)

Ospemifene

Drug updated on 9/4/2024

Dosage FormTablet (oral; 60 mg)
Drug ClassEstrogen agonists/antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
  • For the treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause.

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • Osphena (ospemifene) is indicated for the treatment of moderate to severe dyspareunia and moderate to severe vaginal dryness, symptoms of vulvar and vaginal atrophy due to menopause.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Ospemifene demonstrated comparable efficacy to other active therapies for treating moderate to severe postmenopausal vulvovaginal atrophy (VVA), with no statistically significant differences observed in most efficacy outcomes, including changes in superficial and parabasal cells, vaginal pH, and the most bothersome symptom of vaginal dryness or dyspareunia.
  • Among breast cancer survivors with VVA symptoms, ospemifene did not show an increased risk of breast cancer recurrence; however, the effectiveness of ospemifene relative to other hormonal treatments in terms of symptom relief was not explicitly compared.
  • In the context of sexual dysfunction and vaginal atrophy in postmenopausal women, ospemifene's efficacy was not specifically compared to other treatments, and no direct comparative effectiveness data were provided in the systematic review.
  • Ospemifene demonstrated no statistical difference in safety outcomes compared to other active therapies for postmenopausal women with VVA, with posttreatment endometrial thickness values remaining below the clinical threshold of 4 mm, and no cases of endometrial carcinoma or hyperplasia observed in trials up to 52 weeks.
  • Among breast cancer survivors, ospemifene did not increase the risk of breast cancer recurrence, though the safety data, particularly concerning patients on aromatase inhibitors, is limited and requires further investigation.
  • There is no population types or subgroups information available in the reviewed studies.